Background and objectivesImpacts of mindfulness-based programs on blood pressure remain equivocal, possibly because the programs are not adapted to engage with determinants of hypertension, or due to floor effects. Primary objectives were to create a customized Mindfulness-Based Blood Pressure Reduction (MB-BP) program, and to evaluate acceptability, feasibility, and effects on hypothesized proximal self-regulation mechanisms. Secondary outcomes included modifiable determinants of blood pressure (BP), and clinic-assessed systolic blood pressure (SBP).MethodsThis was a Stage 1 single-arm trial with one year follow-up. Focus groups and in-depth interviews were performed to evaluate acceptability and feasibility. Self-regulation outcomes, and determinants of BP, were assessed using validated questionnaires or objective assessments. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants’ mindfulness skills towards modifiable determinants of blood pressure.ResultsAcceptability and feasibility findings showed that of 53 eligible participants, 48 enrolled (91%). Of these, 43 (90%) attended at least 7 of the 10 MB-BP classes; 43 were followed to one year (90%). Focus groups (n = 19) and semi-structured interviews (n = 10) showed all participants viewed the delivery modality favorably, and identified logistic considerations concerning program access as barriers. A priori selected primary self-regulation outcomes showed improvements at one-year follow-up vs. baseline, including attention control (Sustained Attention to Response Task correct no-go score, p<0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p<0.001). Several determinants of hypertension were improved in participants not adhering to American Heart Association guidelines at baseline, including physical activity (p = 0.02), Dietary Approaches to Stop Hypertension-consistent diet (p<0.001), and alcohol consumption (p<0.001). Findings demonstrated mean 6.1 mmHg reduction in SBP (p = 0.008) at one year follow-up; effects were most pronounced in Stage 2 uncontrolled hypertensives (SBP≥140 mmHg), showing 15.1 mmHg reduction (p<0.001).ConclusionMB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.

Background Hypertension is a leading risk factor for cardiovascular disease. Despite availability of effective lifestyle and medication treatments, blood pressure (BP) is poorly controlled in the United States. Mindfulness training may offer a novel approach to improve BP control. The objective was to evaluate the effects of Mindfulness‐Based Blood Pressure Reduction (MB‐BP) versus enhanced usual care control on unattended office systolic BP. Methods and Results Methods included a parallel‐group phase 2 randomized clinical trial conducted from June 2017 to November 2020. Follow‐up time was 6 months. Outcome assessors and data analyst were blinded to group allocation. Participants had elevated unattended office BP (≥120/80 mm Hg). We randomized 201 participants to MB‐BP (n=101) or enhanced usual care control (n=100). MB‐BP is a mindfulness‐based program adapted for elevated BP. Loss‐to‐follow‐up was 17.4%. The primary outcome was change in unattended office systolic BP at 6 months. A total of 201 participants (58.7% women; 81.1% non‐Hispanic White race and ethnicity; mean age, 59.5 years) were randomized. Results showed that MB‐BP was associated with a 5.9‐mm Hg reduction (95% CI, −9.1 to −2.8 mm Hg) in systolic BP from baseline and outperformed the control group by 4.5 mm Hg at 6 months (95% CI, −9.0 to −0.1 mm Hg) in prespecified analyses. Plausible mechanisms with evidence to be impacted by MB‐BP versus control were sedentary activity (−350.8 sitting min/wk [95% CI, −636.5 to −65.1] sitting min/wk), Dietary Approaches to Stop Hypertension diet (0.32 score [95% CI, −0.04 to 0.67]), and mindfulness (7.3 score [95% CI, 3.0–11.6]). Conclusions A mindfulness‐based program adapted for individuals with elevated BP showed clinically relevant reductions in systolic BP compared with enhanced usual care. Mindfulness training may be a useful approach to improve BP. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT03256890 and NCT03859076.

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